Expansile device for use in blood vessels and tracts in the body and method

ABSTRACT

A device for expansion within a blood vessel having a wall defining a lumen in the body. The device comprises an elongated tubular member having proximal and distal extremities and having a longitudinal axis. An expansile member is carried by the distal extremity of the elongated tubular member and is movable between contracted and expanded configurations. A deformable membrane having proximal and distal outer surfaces at least partially covers the expansile member in the expanded configuration. The proximal and distal outer surfaces have substantially different configurations when the expansile member is in the expanded configuration. Deployment means is carried by the proximal extremity of the elongated tubular member and is coupled to the expansile member for moving the expansile member between the contracted and expanded configurations. A handle assembly is carried by the proximal extremity of the elongated tubular member and coupled to said deployment means.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation-in-part of and claims benefit ofpriority from U.S. patent application Ser. No. 10/272,508, filed Oct.15, 2002 and issued as U.S. Pat. No. 6,656,207, which is a continuationof U.S. patent application Ser. No. 09/528,574, filed Mar. 20, 2000 andissued as U.S. Pat. No. 6,464,712 on Oct. 15, 2002, which is acontinuation-in-part of U.S. patent application Ser. No. 09/241,680,filed Feb. 1, 1999 and issued as U.S. Pat. No. 6,056,770 on May 2, 2000,which is a continuation-in-part of U.S. patent application Ser. No.08/972,383, filed Nov. 18, 1997 and issued as U.S. Pat. No. 5,922,009 onJul. 13, 1999, which is a continuation-in-part of U.S. patentapplication Ser. No. 08/798,870, filed Feb. 11, 1997 and issued as U.S.Pat. No. 5,782,860 on Jul. 21, 1998. The above-identified U.S. PatentApplications are each incorporated herein by reference.

BACKGROUND OF THE INVENTION

This invention relates to an expansile device for use in vascular accesstracts and non-vascular tracts in the human body and method and moreparticularly for percutaneous occlusion of vascular access sites in thehuman body.

Percutaneous access to the blood vessels and organs of the human bodyfor diagnosis and treatment of disease processes has heretofore beenaccomplished.

Percutaneous vascular procedures are performed involving the coronary,peripheral and cerebral vasculature. These procedures include coronaryand peripheral angiography, angioplasty, atherectomies, coronaryretroperfusion and retroinfusion, cerebral angiograms, treatment ofstrokes, cerebral aneurysms and the like. Patients undergoing suchprocedures are often treated with anti-platelet drugs, anticoagulantssuch as heparin, thrombolytics, or a combination thereof, all of whichinterfere with coagulation making it more difficult for the body to seala puncture site. Various devices and methods have heretofore beenutilized, however, they all have had deficiencies, including the use ofcomplicated devices and methods. In addition, difficulties are stillencountered in obtaining good seals. There is therefore a need for adevice and method for percutaneous access and occlusion of vascularaccess sites and other puncture sites and natural tracts in the humanbody which overcome the deficiencies of prior art devices and methods.

BRIEF SUMMARY OF THE INVENTION

In general, it is an object of the present invention to provide anexpansile or closure device and method for percutaneous access andocclusion of vascular access sites, other puncture sites and naturaltracts involving various organs having lumens or cavities in the humanbody which will make possible a positive seal of the puncture site ortract promoting rapid healing of the puncture site or tract.

Another object of the invention is to provide a closure device andmethod of the above character which can be easily and reliably used.

Another object of the invention is to provide a closure device andmethod of the above character which permits easy placement of the devicewithout measuring or sizing of the tract or device.

Another object of the invention is to provide a closure device andmethod of the above character which can be deployed or made operativewith one maneuver or movement.

Another object of the invention is to provide a closure device andmethod of the above character which can be deployed and is effective inseverely tortuous vessels.

Another object of the invention is to provide a closure device andmethod of the above character which enables continued substantiallyunobstructed blood flow during deployment and use of the closure device.

Another object of the invention is to provide a closure device andmethod of the above character in which no foreign body remains in theblood vessel.

Another object of the invention is to provide a closure device andmethod of the above character that permits early ambulation of patientsand avoids prolonged bed rest.

Another object of the invention is to provide a closure device andmethod of the above character which reduces the risk of bleeding,formation of arteriovenous fistula, formation of pseudoaneurysm,thrombosis with distal embolization and infection.

Another object of the invention is to provide a closure device andmethod of the above character that reduces the risk of causing ischemiaof an extremity.

Another object of the invention is to provide a closure device andmethod of the above character that is inexpensive, quick, safe, easy touse and is disposable.

Additional objects and features of the invention will appear from thefollowing description in which the preferred embodiments and the methodsusing the same are described in conjunction with the accompanyingdrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The following drawings should be read with reference to the detaileddescription. Like numbers in different drawings refer to like elements.The drawings, which are not necessarily to scale, illustratively depictembodiments of the present invention and are not intended to limit thescope of the invention.

FIG. 1 is a side-elevational view partially in section of an expansileor closure device for obtaining percutaneous access and occlusion oftracts and punctures in the human body incorporating the presentinvention without the tip guide and having the expansile member in adeployed or expanded position.

FIG. 2 is a side-elevational view partially in section of the device inFIG. 1 with the expansile assembly in a de-deployed or contractedconfiguration.

FIG. 3 is an exploded side-elevational view in section showing thehandle assembly and stop mechanism of the device of FIGS. 1-2.

FIG. 4 is a cross-sectional view taken along the line 4-4 of FIG. 3.

FIG. 5 is a cross-sectional view extending distally for severalmillimeters taken along the line 5-5 of FIG. 3.

FIG. 6 is a side-elevational view partially in section of anotherembodiment of the device of the present invention without the tip guideand having the expansile member in the expanded configuration.

FIG. 7 is a side-elevational view partially in section of the device inFIG. 6 with the expansile assembly in a de-deployed or contractedconfiguration.

FIGS. 8 a and 8 b are exploded cross-sectional views of the distalextremity of another embodiment of the device of the present inventionshowing the expansile assembly in the expanded configuration occluding apuncture in a blood vessel. FIG. 8 a shows the expansile assembly of thedevice without proximal tension applied thereto and FIG. 8 b shows theexpansile assembly of the device with proximal tension applied thereto.

FIG. 9A-9D are cross-sectional views of a distal end of the expansibledevice illustrating yet another embodiment according to the principlesof the present invention.

FIG. 10A-10E are cross-sectional views of a distal end of the expansibledevice illustrating still another embodiment according to the principlesof the present invention.

FIG. 11A-11E are cross-sectional views of a distal end of the expansibledevice illustrating a further embodiment according to the principles ofthe present invention.

DETAILED DESCRIPTION OF THE INVENTION

In general, the device for expansion within an organ having a walldefining a lumen or cavity in the body of the present inventioncomprises an elongated tubular member having proximal and distalextremities and having a longitudinal axis. An expansile member iscarried by the distal extremity of the elongated tubular member and ismovable between contracted and expanded configurations. A deformablemembrane at least partially covering the expansile member is sized so asto be capable of expanding as the expansile member moves from thecontracted configuration to the expanded configuration. Deployment meansare carried by the proximal extremity of the elongated tubular memberand coupled to the expansile member. The deployment means are adapted tobe capable of moving the expansile member between the contracted andexpanded configurations. A handle assembly is carried by the proximalextremity of the elongated tubular member and coupled to the deploymentmeans.

More specifically, as shown in FIGS. 1-2, the expansile device 21 of thepresent invention comprises a first elongate tubular member 22,preferably a flexible elongate tubular member 22, formed of a suitableplastic material, preferably a cast thermoset material such aspolyimide. The inner and outer surfaces of the polyimide material may becoated with a lubricious material such as Teflon™. Alternatively, thethermoset material may be a polyimide-Teflon™ composite in order toprovide the desired lubricious inner and outer surfaces. The firstflexible elongate tubular member 22 has proximal and distal extremities23 and 24 with a longitudinal axis extending from the proximal 23 to thedistal extremity 24 and is provided with a first lumen 26 circular incross section which, as shown, may be centrally disposed extending fromthe proximal extremity 23 to the distal extremity 24.

The flexible elongate tubular member 22 is of a suitable size, as forexample having an outer diameter ranging from 1-9 French correspondingto an outer diameter ranging from approximately 0.008″ to 0.050″,preferably approximately 0.022″-0.026″, and a suitable length, as forexample 10-150 centimeters, preferably 33 centimeters ±1 centimeter. Thefirst lumen 26 in the first flexible elongate tubular member 22 may havean inside diameter of approximately 0.003″ to 0.030″, preferably0.012″-0.014″.

Expansile means in the form of an expansile assembly 31 is carried bythe distal extremity 24 of the flexible elongate tubular member 22 andis movable between contracted and expanded positions. A deploymentmechanism is carried by the proximal extremity 23 of the flexibleelongate tubular member 22 and adapted to be operated by the human handfor movement from a contracted position or configuration to an expandedposition or configuration.

The expansile assembly 31 includes an expansile member 32 and a membrane33 which at least partially covers the expansile member 32. As shown inFIG. 2, the expansile member 32 is in a form having a complexgeometrical configuration, preferably a ellipsoidal, helical orbi-conical coil configuration 34, when in the free, unconstrained state.As hereinafter discussed, the helical coil 34 is formed of a suitablematerial such as a shape memory or superelastic material which can beelongated, contracted or constrained without permanent deformation but,at body temperature, when freed or unconstrained returns to thememorized helical coil configuration 34 to which it has been annealed.One material found to be particularly suitable for such an applicationis a nickel/titanium alloy wire, often called Nitinol™ wire.

The correctly annealed and configured helical coil 34 has a plurality ofgenerally circular turns, loops or coils creating, preferably, aproximal coil, loop or turn 66, a middle coil, turn or loop 67 and adistal coil, turn or loop 68 as shown in FIG. 1. The proximal, middleand distal coils 66, 67 and 68 are generally nonplanar with respect toone another. At least a portion of the proximal coil 66 and a portion ofthe distal coil 68 each lie in a plane that is generally parallel to oneanother and generally perpendicular to the longitudinal axis of theflexible elongate tubular member 22. The middle coil 67 is non-planarand helical as it connects the proximal and distal coils 66 and 68 sothat the unconstrained or free helical coil 34 assumes a substantiallyellipsoidal or bi-conical shape.

The middle coil 67, when freed or unconstrained, has a suitable diameterranging from 3 to 10 millimeters, preferably, greater than or equal to5.33 millimeters (16 French). As hereinafter discussed, duringdeployment the middle coil 67 is partially flattened and constrained bythe membrane 33 to maintain a diameter of approximately 16 French inorder to overlap a puncture site or other opening to assist in occludingthe opening. The proximal and distal coils 66 and 68 are ofapproximately equal size and diameter ranging from 1 to 5 millimeters,preferably 2 to 3 millimeters. The unconstrained helical coil 34configuration has a distance from the proximal 66 to the distal 68 coilof approximately 4-8 millimeters. As hereinafter discussed, the helicalcoil 34 is retracted into the flexible elongate tubular member 22 toobtain the de-deployed configuration wherein the contracted, constraineddiameter corresponds to the approximate diameter of the Nitinol wireused to construct the expansile member 32, ranging from 0.002″ to0.010″, preferably 0.0055″. As hereinafter discussed, the expansilemember 32 is provided with a straight portion 73 of Nitinol wireproximal to the helical coil 34 having a length of approximately 50millimeters ±2 millimeters.

The deployment means or mechanism 80 includes a push-pull element ormember 81, preferably in the form of a wire 81 with proximal and distalextremities 82 and 83, which is slidably disposed in and extends throughthe first lumen 26 of the flexible elongate tubular member 22 ashereinafter discussed. The push pull member 81 is formed of a suitablematerial such as stainless steel in order optimize torque transmission.The push pull member 81 has a suitable diameter ranging fromapproximately 0.005″-0.020″, preferably 0.010″. In order to provide foroptimal torque transmission after being bonded to the Nitinol expansilemember 32 as hereinafter discussed, the distal extremity 83 of the pushpull wire 81 provided with a tapered portion. The tapered portion has alength ranging from approximately 1.0 centimeters to 6.0 centimeters.

A hypotube connector is provided for joining the tapered portion of thepush pull wire 81 to the proximal straight portion 73 of the Nitinolwire 61. The hypotube connector has a length ranging from approximately2.0 centimeters to 4.5 centimeters, an inner diameter ranging fromapproximately 0.006″-0.008″ and an outer diameter ranging fromapproximately 0.009″-0.012″. During manufacture, the tapered portion ofthe push-pull wire 81 is inserted into one end of the hypotube connectorand the proximal end of the straight portion 73 of the Nitinol wire isinserted into the opposite, distal end of the connector whereupon allare bonded together within the hypotube connector utilizing a suitableadhesive such as Loctite™ 648. It should be appreciated that, bygrinding and shaping a single length of Nitinol wire, one piece can beutilized having a distal thinner segment which can be shaped into thecoil. This obviates the requirement of having a stainless steelpush-pull wire, hypotube and connection therebetween.

The proximal end 23 of the flexible elongate tubular member 22 isprovided with an expander tube or strain relief member 113 made of asuitable material, such as polycarbonate, having an inner diameterranging from 5.024″-0.028″, an outer diameter ranging from 0.030″-0.036″and a length of approximately 24-26 millimeters. The expander tube 113is disposed over the proximal end 23 of the tubular member 22 so thatthe proximal end of the expander tube 113 is positioned approximately0.5-1.0 millimeters distal to the proximal most end 23 of the tubularmember 22 and suitably bonded thereto using an appropriate adhesive suchas cyanoacrylite.

As shown in FIGS. 1-3, a stop mechanism or means 121 is provided tocontrol the range of movement or travel of the push-pull wire 81 duringdeployment and de-deployment of the expansile assembly 31. The stopmechanism 121 comprises first and second, or inner and outer, slidablyand rotatably nested, or coaxially carried stop members or handles 122and 123 which are formed of polycarbonate and mounted as hereinafterdiscussed.

The inner stop member or handle 122 is formed of a polycarbonateextrusion which, initially, has an outer configuration that is square incross section and has a dimension ranging from approximately0.015″-0.050″, preferably approximately 0.038″. The inner member 122 hasa length of approximately 60 millimeters ±5 millimeters and carries acircular in cross section lumen extending therethrough, the lumen havinga diameter ranging from approximately 0.010″-0.016″. During manufacture,the inner stop member 122 is twisted or turned in order to form athreaded outer surface or helical groove 125 therein which carriespitches of varying degrees or distances. As shown in FIG. 3, the thread125 carries, preferably, a greater pitch on the proximal segment of theinner handle 122 and a lesser pitch on the distal segment of the innerhandle 122.

The distal end of the inner handle 122 carries a collar 124 formed ofcyanoacrylite and having a length of approximately 3-5 millimeters andan outer diameter ranging from approximately 0.024″-0.040″. The outercollar 124 is coaxially adhesively mounted over the inner handle 122 sothat the distal end of the collar 124 is disposed slightly proximal tothe distal end of the inner handle tube 122 by several millimeters.

As seen in FIG. 3, an inner handle support hypotube 127 is coaxially,adhesively mounted upon the proximal extremity 82 of the push-pull wire81 using, preferably, cyanoacrylite so that the proximal end thereof isflush with the proximal most tip of the push pull wire 81. The supporthypotube 127 has an inner diameter ranging from 0.008″ to 0.018″,preferably approximately 0.012″ and an outer diameter ranging from0.015″ to 0.028″, preferably approximately 0.020″. The inner handle 122is coaxially, adhesively mounted upon the support hypotube 127, alsousing an appropriate adhesive such as cyanoacrylite, so that theproximal end 82 of the push-pull wire 81 and the support hypotube 127carried thereby extend through and proximal of the inner handle 122 ashereinafter discussed.

The outer handle stop member 123 is constructed from metal, polymer,plastic, or like materials, and preferably comprises stainless steel.The stop member 123 has a length of approximately 65 millimeters ±5millimeters, an inner diameter ranging from approximately 0.020″-0.060″,preferably approximately 0.055″, and an outer diameter ranging fromapproximately 0.035″-0.080″, preferably approximately 0.066″. Inaddition, the proximal end of the outer stop member 123 is provided witha slotted stop segment or inner nut or bushing 126 which has an outerdiameter equal to the outer diameter of the outer stop member 123 andwhich is formed so that the slot 126 is square in shape and has adimension which is, preferably, approximately 0.042″ or slightly largerthan the square, outer dimension of the inner handle 122. As shown inFIGS. 1-3, the distal end of the outer handle 123 is secured to theproximal extremity 23 of the elongate tubular member 22 by beingadhesively secured to the proximal end of the expander tube 113 using,preferably, an ultra violet cured adhesive. As shown in FIGS. 1-3, afreely rotatable handle assembly 131 is provided and carried by thesegments of the push-pull wire 81 and inner handle support hypotube 127extending proximal to the inner handle 122. The rotatable handleassembly 131 comprises a rotatable hypotube casing 132, a rotatablecollar 133, a back stop member 134 and a handle grip or sleeve 136 ashereinafter discussed. The complete assembly 131 is sized so as to becapable of being passed through a conventional introducer sheath ashereinafter described. As such, it has a maximum diameter that is nogreater than, and, preferably less than, approximately two to threetimes the diameter of the elongate tubular member 22.

The hypotube casing 132 is of appropriate size, having a length ofapproximately 15 millimeters, an inner diameter of approximately 0.035″and an outer diameter of approximately 0.042″. The hypotube casing 132is covered with a handle grip or sleeve 136 made of an approximately 15millimeters length of RNF heat shrink tubing having a thickness ofapproximately 1/16″ and which is applied in a conventional manner.

The rotatable collar 133 is constructed of hypotube having a length ofapproximately 8 millimeters, an inner diameter of approximately 0.025″and an outer diameter of approximately 0.032″. The collar 133 isadhesively, coaxially mounted within the casing 132 using an appropriateadhesive, preferably cyanoacrylite, so that the distal end of the collar133 is flush with the distal end of the casing 132. The rotatable collar133 carried by the casing 132 is coaxially rotatably mounted over theproximal end of the inner handle support hypotube 127 as shown in FIGS.1-3.

A back stop member 134 constructed of stainless steel hypotube andhaving a length of approximately 4 millimeters, an inner diameter ofapproximately 0.025″ and an outer diameter of approximately 0.032″ isadhesively, coaxially mounted (also preferably using cyanoacrylite) onthe proximal end of the inner handle support tube 127 proximal to therotatable collar 133 so that the proximal end of the stop member 134 isflush with the tip of the proximal end of the inner handle support tube127.

As assembled, the push-pull element 81, with the threaded inner handlemember 122 affixed thereto and the collar 124 carried thereby, ismovable longitudinally and rotationally within and in relation to theouter handle member 123 which has its distal extremity secured to theexpander hypotube 113 carried by the proximal extremity 23 of thepolyimide tubular member 22 as hereinbefore discussed. Using the freelyrotatable handle assembly 131, it is movable between a forward or distalmost position wherein the distal end of the inner handle 122 is engagedwith or abutting against the proximal extremity 23 of the polyimidemember 22 and the distal end of the rotatable collar 133 abuts againstthe proximal end of the stop segment 126 of the outer handle member 123and a rearward or proximal most position wherein the collar 124 isengaged with the stop segment 126 carried by the proximal extremity ofthe outer member or handle 123 and the proximal end of the rotatablecollar 133 abuts against the distal end of the back stop member 134. Ashereinafter discussed, these positions correspond to deployed andde-deployed positions and configurations of the expansile assembly 31.

The distal extremity 24 of the flexible elongate tubular member 22 isprovided with a hypotube tip 105 over which the membrane 33 is disposedand moves as hereinafter discussed. The hypotube tip 105 is constructedof 304 stainless steel hypotube, or other suitable material, having anouter diameter ranging from approximately 0.028″-0.040″ and an innerdiameter ranging from 0.024″-0.030″ and which is cut to have a length ofapproximately 3-5 millimeters. The hypotube tip 105 is coaxially mountedover the distal extremity 24 of the polyimide tubular member 22 using,preferably, Loctite so that the tip of the distal extremity 24 of thetubular member 22 is flush with the distal end of the hypotube tip 105.

A tip guide (not shown) is slidably carried by the polyimide tubularmember 22 for use as hereinafter discussed. The tip guide is constructedof 1/16″ RNF 100 Shrink tubing. The tip guide has a longitudinal axisand a length of approximately 32 millimeters. In addition, the distalportion of the tip guide is provided with a larger, non shrunk end.

As hereinbefore discussed, the expansile assembly 31 also carries adeformable flexible membrane 33 which is carried by and secured to thedistal extremity 24 of the elongate tubular member 22 as shown in FIGS.1-2.

The membrane 33 is formed of Polyblend™ Extrusion having an internal orinner diameter of 0.020″, an outer diameter of 0.036″ and which is cutto have a length of approximately 1 centimeter ±1. The proximal end ofthe membrane 151 is secured to the proximal end of the hypotube tip 105,using an appropriate material such as Loctite 496 adhesive, so that thedistal membrane tip 152 extends distal to the tip of the distalextremity 24 of the flexible elongate tubular member 22 and so thatdistally extending portion of the membrane tip 152 has a length,measured from the distal end of the hypotube tip 105 to the distal endof the membrane tip 152, of approximately 1.0-1.5 millimeters. Theextruded membrane tip 152 is subsequently sealed or closed with anextrusion beading 153 as hereinafter discussed.

The beading 153 is made of the same or similar Polyblend material in theform of a solid plug having a diameter of 0.025″ and a length of 5millimeters. This segment of extrusion beading 153 is inserted into thedistal, open end of the membrane tip 152 approximately 0.5-0.75millimeters and heat bonded to the membrane tip 152 so that the distaltip of the beading 153 is flush with the distal end of the membrane tip152.

Operation and use of the expansile device 21 of the present invention issimilar to that disclosed in U.S. Pat. No. 5,782,860, issued Jul. 21,1998 and U.S. Pat. No. 5,922,009, issued on Jul. 13, 1999, the relevantportions of which are hereby incorporated by reference in theirentirety.

Prior to deployment, the expansile member 32 is fully or completelyretracted within the distal extremity 24 of the flexible elongatetubular member 22 which causes the expansile member 32 to assume acontracted configuration. Insertion of the device 21 in the contractedconfiguration into a conventional sheath introducer (not shown) isfacilitated by using the tip guide 106 carried by the polyimide tubularmember 22 as hereinbefore discussed. Prior to inserting the device 21into the sheath introducer, the operator slides the tip guide 106distally, from the middle of the polyimide tubular member 22 to thedistal extremity 24 thereof. When the distal end of the tip guide 106 isdisposed slightly distal to the distal extremity 24 of the polyimidetubular member 22 and the membrane 33 carried thereby, the distal end ofthe tip guide 106 is frictionally fit into the conventional one-wayvalve carried by the sheath introducer, thus urging the valve into aslightly opened position. The distal extremity 24 of the elongatetubular member 22 can then be easily and atraumatically introducedthrough the valve of the introducer and advanced distally therein untilthe device is aptly disposed through the tract opening or, in the caseof a vascular puncture, in the blood vessel as hereinbefore discussed.By not relying on the tip of the distal extremity 24 of the device 21 toopen the valve of the introducer sheath, the integrity of the membrane33 carried thereby is maintained.

Once appropriately disposed in a tract or puncture site, deployment ofthe device 21 is accomplished by using the freely rotatable handleassembly 131 to operate the deployment means 80 to move the push-pullwire 81 distally to urge the expansile member 32 distally out of thelumen 26 of the flexible elongate tubular member 22, into the membrane33. As soon as the distal part of the expansile member 32 clears thelumen 26, it begins an attempt to expand into its shape memory,predetermined, or free configuration which corresponds to theellipsoidal, helical coil configuration 34. However, as hereinafterdiscussed, the expansile member 32 is prevented from fully expandinginto its free shape configuration as a result of the membrane 33partially constraining the expansion process.

More specifically, the distal coil 68 operates to expand the membrane 33initially to a small degree. This initial process avoids sudden grossdistortion of the membrane 33. As soon as the expansile member 32 movesfurther distally out of the lumen 26 and expands into the membrane 33,the non-adherent portion of the membrane 33, distal to the portion ofmembrane 33 fixed to the distal extremity 24 of the elongate tubularmember 22, preferentially begins to move and assume the planarconfiguration due to the lubricious surface of the hypotube tip 105 andthe ease with which the membrane 33 slides thereupon. Expansion proceedswith the middle coil 67 causing the membrane 33 to expand to its desiredsize. The proximal coil 66 expands last, to centralize and stabilize theconfiguration so that the push-pull wire 81 is centered with respect tothe middle coil 67 and the fully expanded membrane 33.

Throughout the deployment process, as the coil 34 is expanding andseeking its memorized configuration it is rotating in a leftward orcounter-clockwise direction. As a result, the push-pull member 81 isbeing torqued by the slightly rotating coil 34 in the same direction.This torque requires that the push-pull member 81 be permitted to rotatecounter-clockwise in order for the coil 34 to operatively rotate andexpand within, and without damaging, the membrane 33 as hereinafterdiscussed. Furthermore, the amount of torque developed by the expandingcoil 34 varies so that more torque is developed and, therefore, morerotation of the push-pull member 81 is optimal, during deployment of thedistal portion of the coil 34. In all, the push-pull member 81 rotatesapproximately 1 to 3, preferably approximately 1.5 to 2, revolutions. Ashereinafter discussed, when the operator pushes the freely rotatablehandle 131 distally, the variable pitch threaded inner handle 122effects such a counter-clockwise, controlled, torqued deployment.

The counter-clockwise rotation during deployment is provided andcontrolled by rotation means or mechanism which comprises the threaded125 portion of the inner handle 122 traveling longitudinally androtationally through the square shaped inner bushing or nut 126 of theouter handle member 123. The lesser or tighter pitch of the thread 125at the distal segment of the inner handle 122 causes greater rotationduring deployment of the distal coil 68. It should be appreciated thatthe direction of rotation of the expansile member depends upon theorientation in which the coil is manufactured. It is, therefore, onlyimportant that the rotation means be manufactured to provide controlledrotation in the same direction as that which the coil seeks duringexpansion according to its manufactured orientation.

Furthermore, the hypotube casing 132 and the rotatable collar 133 enablethe operator to ergonomically and stably maintain a hand hold on thehandle 131 of the device 21 during operation thereof without having toremove his or her hand in order to accommodate or permit rotation of theinner handle member 122. This is effected by the free rotation of theinner handle support tube 127, the push-pull member 81 and the back stopmember 134 within the casing 132 and rotatable collar 133. That is, thehandle assembly 131 accommodates rotation of the deployment means 80 andexpansile member 32 without, or independent of, the portions of thehandle assembly 131 held by the operator.

During expansion of the expansile member 32 the membrane 33 covering thecoil 34 simultaneously constrains the coil 34, thus exertingcounteractive or countervailing contractile forces on the expanding coil34 which is seeking its memorized, ellipsoidal, bi-conical, free orunconstrained configuration. Thus, the membrane 33 does not expandpassively. Rather, the expanding coil 34 forcibly expands the membrane33 to cause the non-planar turns or coils 66, 67 and 68 of the coil 34to assume a substantially planar or disk-like configuration with themembrane 33 being taut and disposed on opposite sides of the expansilemember 32 to form an expansile assembly 31 which when expanded isgenerally perpendicular to the longitudinal axis of the first flexibleelongate tubular member 22. The expansile member 32, when so deployedinto this constrained, partially expanded configuration, is sufficientlyrigid and robust so as to provide a supporting framework for themembrane 33 to keep it taut and capable of occluding an opening. Inaddition, deployment of the expansile assembly 31 is effected withoutobstructing or impinging on walls of the smallest openings in the bodydue to the uniquely small profile and expansion mechanics of the helicalcoil 34 during deployment and de-deployment as hereinbefore discussed.

Another embodiment of the expansile device of the present invention isshown in FIGS. 6 and 7. Device 221 is similar to device 21 with theprinciple difference being in the expanded configuration of device 221.Thus all parts of closure device 221 that are identical to those ofdevice 21 carry the same numbers as those of the closure device 21. Inaddition, device 221 is provided with means for urging the membrane 33into a partially convex configuration during movement of expansilemember 32 between contracted and expanded configurations to seal apuncture. Inner handle 122 of device 221 carries a piston 222 whichreplaces collar 124 in device 21. Piston 222 is made of any suitablematerial, preferably a compressible or deformable silicone O-ring, andis of an appropriate diameter slightly larger than the inner diameter ofouter handle 123. Piston or O-ring 222 is mounted to inner handle 122 inan appropriate manner similar to that hereinbefore described for collar124 of device 21. Outer handle 123 is provided with a small transversehole 223 located at a predetermined, appropriate point along thelongitudinal axis of outer handle 123. Hole 223 has an appropriatediameter ranging from approximately 0.005-0.050 inches, preferablyapproximately 0.020 inches. Operation and use of device 221 is the sameas that of device 21.

The primary difference between device 21 and device 221 is theconfiguration that membrane 33 assumes during deployment, when expansileassembly 31 is in the fully expanded configuration, occluding or sealinga vascular puncture. During deployment of device 221, as inner handle122 rotates and slides distally within outer handle 123, piston 222maintains a substantially air-tight seal between inner and outer handles122 and 123. Thus, as long as piston 222 is disposed proximal of hole223, air naturally contained between inner and outer handles 122 and 123and within lumen 26 of elongate tubular member 22 is displaced or ventedout of outer handle 123 through hole 223 as inner handle 122 movesdistally. When piston 222 becomes disposed distal of hole 223, continueddistal movement of inner handle 122 within outer handle 123 forciblydisplaces a predetermined volume of air, retained both in between innerand outer handles 122 and 123 and within lumen 26 of elongate tubularmember 22, into membrane 33.

As hereinbefore described in conjunction with device 21, duringexpansion of device 221, the non-adherent portion of membrane 33, distalto the portion of membrane 33 fixed to distal extremity 24 of elongatetubular member 22, begins to move preferentially. With the compressionand introduction of the small quantity of air from lumen 26, thedeployment of coil 34 into membrane 33 causes the proximal outer surface224 of membrane 33 to assume a substantially different configurationfrom the distal outer surface 226 of membrane 33 as seen in FIG. 1. Thetaper of proximal outer surface 224 assumes a substantially convexconfiguration in the expanded configuration instead of the substantiallydisk-like configuration of the proximal side of membrane 33 in expandeddevice 21. Similar to membrane 33 of device 21, distal outer surface 226of membrane 33 of device 221 maintains a disk-like configuration whendevice 221 is in the fully expanded configuration within the vascularpuncture.

Due to the durometer of the membrane material, the alteration in taperof proximal outer surface 224 of membrane 33 of device 221 occurs atpressures very close to the mean arterial pressure of a human patient.Thus, the disk-like configured distal outer surface 226 of membrane 33of expansile assembly 31 is naturally urged or forced laterally byarterial blood flow within the vessel, towards the inner wall of thevessel whereby the tapered proximal outer surface 224 is caused to moretightly occlude the puncture in the wall of the vessel without theexpansile assembly 31 obstructing ongoing blood flow.

Another embodiment of the expansile device of the present invention isshown in FIG. 8. Device 231 is similar to device 221 with the principledifference being in the expanded configuration of device 231. Thus allparts of closure device 231 that are identical to those of device 221carry the same numbers as those of the closure device 221. In addition,device 231 is provided with means for urging the proximal outer surface224 of membrane 33 into a convex configuration during movement ofexpansile assembly 31 between contracted and expanded configurationsthat is distinct from the urging means of device 221. Expansile member32 is provided with an additional proximal coil 232. Additional proximalcoil 232 is of substantially equal size and diameter to proximal coil66. In the free or unconstrained configuration of helical coil 34,proximal coils 66 and 232 lie immediately adjacent to one another liketwo coils of a tightly wound spring. Thus, the overall unconstrainedconfiguration and size of coil 34 is essentially unchanged from that ofdevice 221.

Operation of device 231 is substantially the same as that of device 21with the main difference being in the expanded configuration whichdevice 231 assumes. In addition, second proximal coil 232 requires that,in order to be fully deployed, device 231 be provided with a slightlyincreased stroke length (not shown). During movement of the expansilemember 32 from the contracted to the expanded configuration, due to theadditional stiffness and bulk provided by tightly apposed proximal coils66 and 232, the proximal outer surface 224 of membrane 33 is tented ortapered between the two coils 66 and 232 and assumes a substantiallyconvex configuration as opposed to the substantially disk-likeconfiguration of both sides of membrane 33 assumed by device 21 in theexpanded configuration. Double coils 66 and 232 stretch or unwind lesswhen tension is applied to fully deployed device 231. Thus, proximalouter surface 224 of membrane 33 is more firmly supported when device231 is under tension. In addition, as shown in FIG. 8b, depending on thestiffness provided the proximal coils 66 and 232, they can be made toseparate slightly under tension so that during deployment of device 231,proximal coil 66 remains inside and up against the inner vessel wall ofthe puncture while proximal coil 232 is made to pull proximally, throughthe arteriotomy or puncture in the vessel, and come to rest on the outerwall thereof. In this manner the inner and outer walls of the arteryare, essentially, sandwiched or gently compressed between proximal coils66 and 232 whereupon any additional external proximal tension may beeliminated or discontinued. This is particularly useful for largerarteriotomies or punctures.

Referring now to FIGS. 9A through 9D, another embodiment of theexpansible device 300 for use in a body lumen or tract according to theprinciples of the present invention is illustrated. The expansibledevice 300 generally comprises a tubular member 22 having a proximal end23 and a distal end 24. An expansible member 302 is disposed on thedistal end 24 of the tubular member 22. The expansible member 302 has acontracted configuration and an expanded configuration. The expandedconfiguration comprises a conical spring shape in a free, unconstrainedstate. A deformable membrane 33 is at least partially disposed over theexpansible member 302 in the expanded configuration.

The expansible member 302 may comprise a coil or spring of wire formedfrom suitable materials such as shape memory, superelastic material (e.g., Nitinol™), or any material which may be elongated, contracted orconstrained without permanent deformation, but when freed orunconstrained (i.e., at body temperature) returns to the normal conicalcoil configuration. The diameter of the wire may range from about 0.005inch to about 0.012 inch, preferably from about 0.006 inch to about0.010 inch. The expansible member 302 may comprise 1 to 10 loops,preferably 3 to 5 loops. The wire is annealed and configured such thatthe coil 302 in the free state has a height, between the first and thelast loop, in a range from about 0.1 inch to about 0.5 inch, preferablyfrom about 0.2 inch to about 0.4 inch.

As shown in FIG. 9B, the expansible member 302 includes a straightportion 73 extending from an apex of the conical shaped expansiblemember 302 to the deployment means 80 of the tubular member 22. Thedeployment means 80 is coupleable to the proximal end 23 of the tubularmember 22 as discussed above in detail. The straight section 73 extendsfrom the smallest loop through a center of the coil 302 towards thelargest loop and beyond. A free end of the coil may be beaded 304 toprotect the membrane 33 when the coil 302 is deployed. The bead 304 mayhave a diameter that is in a range from about 0.001 inch to about 0.010inch larger than the coil diameter. The beading 304 of the coil can beaccomplished by arch welding, laser, or like means.

A method for sealing a puncture site is illustrated in FIGS. 9B-9D. Anexpansible device 300 is provided having a tubular member 22, anexpansible member 302 disposed on a distal end 24 of the tubular member22 moveable between a contracted configuration and an expandedconfiguration, and a deformable membrane 33 at least partially disposedover the expansible member 302 in the expanded configuration. The device300 is inserted in the puncture site 306, which may comprise a bloodvessel wall as shown or a tissue tract. The expansible member 302 isthen deployed to an expanded configuration comprising a conical shape.As shown in FIG. 9B, when the device 300 is deployed, first the largestloop with the beaded tip 304 extends out of the tubular member 22, thenthe smaller loops, and finally a straight portion 73 of the expansiblemember 302. The straight portion 73 extends from the apex of the conicalshape which is orientated away from the puncture site 306. The membrane33 provides a continuous barrier over the expansible member 302,particularly on an outer surface in contact with the puncture site 306to seal the hole and prevent blood from leaking out.

Referring now to FIG. 9C, when the deployed device 300 is placed againstthe wall of the vessel 306 and proximal tension is applied to seat thetip assembly, the coils of the expansible member 302 will compress intoeach other and the cone will transform into a disk shape configuration.As shown in FIG. 9D, further application of proximal tension to thestraight section 73 will cause the vessel wall 306 to protrude out sothat the expansible member 302 is deformed into an inverted conicalshape configuration wherein the apex of the cone is oriented toward thepuncture site 306. The expansible device 300 of FIGS. 9A-9D providesimproved seating of the tip against the puncture site and also enables auser to apply increased tension to the device during the seating processbefore the device is herniated out of the vessel.

Referring now to FIG. 1A, an improved membrane attachment 308 accordingto the principles of the present invention is illustrated. Theexpansible device 310 for use in a body lumen or tract comprises atubular member 22, an expansible member 312 disposed on a distal end 24of the tubular member 22, and a deformable membrane 33 at leastpartially disposed over the expansible membrane 312. In particular, areference stop 314 is disposed between the deformable membrane 33 andthe distal end 24 of the tubular member 22 so as to control an angle ofdeflection of the membrane 33 relative to the tubular member 24.

It has been observed and tested that the attachment point 308 of themembrane 33 to the tubular member 22 changes an angle that is formedbetween the membrane 33 and the tubular member 22 when the device 312 isdeployed. In FIGS. 10B and 10C, an angle α is formed between themembrane 33 and the tubular member 22. In FIGS. 10D and 10E, themembrane attachment 308 is disposed more distally as compared to FIGS.10B and 10C, and an angle β is formed between the membrane 33 and thetubular member 22. A comparison of these illustrations shows that thecloser the attachment point 308 is to the distal end 24 of the tubularmember 22 the more perpendicular the deployed membrane 33 becomes to thetubular member 22 at the attachment point 308 as the angle αis greaterthan the angle β. This feature changes the amount of tension that wouldbe required to herniate a deployed device out of the puncture site. Inparticular, the more perpendicular the deployed membrane is to thetubular member the more is the required pull force to remove thedeployed device out of the vessel. This increase in the allowabletension is advantageous as it provides for improved seating of thedeployed membrane at the arteriotomy site.

Accordingly, a tip stop 314 is employed to provide a reference forconsistent attachment 308 of the membrane 33 to the most distal end 24of the tubular member 22. The reference stop 314 further provides a stopthat prevents the membrane 33 and its attachment means 308 to slideforward when the deployed device is under tension. Moreover, thereference stop 314 provides a reservoir of membrane at deployment timeproximal to the deploying expansible member 312. As shown in FIG. 10A,the reference stop 314 may comprise a hypotube having length in therange from about 0.010 inch to about 0.200 inch, preferably from about0.030 inch to about 0.060 inch. The reference stop 314 has an innerdiameter that is slightly larger than an outer diameter of the tubularshaft 22. The reference stop 314 has an outer diameter that is in arange from about 0.001 inch to about 0.020 inch, preferably from about0.002 inch to about 0.010 inch larger than the outer diameter of thetubular member 22. The deformable membrane 33 comprises a sphericalshape 316 when the expansible member 312 is in the expandedconfiguration, as seen in FIG. 10E. It will be appreciated however thatthe deformable membrane 33 may comprise any of the configurationsdiscussed herein, including a conical shape, bi-conical shape, diskshape, convex shape, etc.

A proximal end 151 of the membrane 33 is attached to the tubular member22 just proximal of the reference stop 314 by variety of means. Forexample, a suture material 318, such as 5-0 braided silk suture, may beused to wrap the membrane end 151 over the tubular member for a lengthof about 0.050 inch to about 0.50 inch, preferably about 0.10 inch toabout 0.20 inch. Alternatively, this may also be accomplished by swagingor crimping a stainless or other metallic tubes of appropriate diameterand length over the membrane end 151. Still further, a preformed coilspring of appropriate wire diameter (e.g., 0.002 inch to about 0.010inch), with appropriate pitch and coil length may be placed over themembrane end 151. The membrane end 151 with the attachment means (e.g.,suture, swaged metal tube, or coil) are then covered with a cover tube105. The cover tube 105, as described above, is may be formed frompolyimide, peak material, or other medical grade material. The covertube 105 should be long enough to extend to a proximal end of thereference stop 314, cover the fastened membrane end 151, and extend toor beyond a proximal end of the fastened membrane end 151. The covertube 105 generally has an inner diameter that is large enough to slideover the fastened membrane end 151 and has a wall thickness ofapproximately 0.001 inch. A proximal end of the cover tube 105 is gluedas indicated by reference numeral 320.

Referring now to FIGS. 11A through 11E, another embodiment of theexpansible device 400 for use in a body lumen or tract according to theprinciples of the present invention is illustrated. The device 400 foruse in a body lumen or tract comprises a tubular member 22 having aproximal end 23 and a distal end 24. A first expansible member 312 isdisposed on a distal end 24 of the tubular member 22. The firstexpansible member 312 has a contracted configuration and an expandedconfiguration comprising a spherical shape. A first deformable membrane33 is at least partially disposed over the first expansible member 312in the expanded configuration. A second expansible member 402 isdisposed proximal the first expansible membrane 312 on a distal end 24of the tubular member 22. The second expansible member 402 has acontracted configuration as shown in FIGS. 11A and 11B and expandedconfiguration comprising a cylindrical shape as shown in FIGS. 1Cthrough 11E.

This design of two expansible members 312 and 402 provided manyadvantages. For example, the first expansible member 312 at the distalend 24 of the tubular member 22 may locate the vessel wall 306 andanchor the device 400 upon deployment. The first expansible member 312also provides temporary hemostasis at the puncture site. The secondexpansible device 402 may be located in the tissue track once the device400 is located and anchored via the first expansible member 312. Thesecond expansible member 402 provides hemostasis means for the tissuetrack as well as counteractive force against the first expansible member312 upon deployment. The second expansible member 402 may also alleviatethe need for an external tensioner. These two members 312 and 402, whendeployed, work against each other by sandwiching and/or compressing thevessel wall 306 at the puncture site. The device 400 may result inenhanced hemostasis of the arteriotomy site and provide means forhemostasis of the tissue track.

Referring now to FIGS. 11C and 11D, the second expansible member 402 maycomprise a variety of embodiments. For example, the second expansiblemember 402 may comprise a membrane 404 which is inflatable with apredetermined volume of air 406 contained within the tubular member 22.As shown in FIG. 11C, this provides at least one of radial expansion, asdepicted by arrows 408, or axial expansion, as depicted by arrows 410,of the second expansible member 402. Alternatively, the secondexpansible member 402 may comprise a coil or spring of wire 412 and asecond deformable membrane 414 at least partially disposed over the coil412 in the expanded configuration, as shown in FIG. 11D, and similar tothe configurations described herein with respect to the first expansiblemember (32, 302, 312). The coil 412 may have a diameter in a range fromabout 0.02 inch to about 0.2 inch and may be constructed from wirehaving a diameter in a range from about 0.005 inch to about 0.02 inch.Additionally, ribs 416 may be formed on an outer surface of the seconddeformable membrane 414 to secure the tubular member 22 against thetissue track and thereby prevent the device 400 from unintentionalsliding or movement. The membranes 404 and 414 may be formed frommaterials as already described with respect to membrane 33. The firstexpansible member 312 may comprise any of the several embodimentsalready discussed above in detail.

Referring now to FIG. 11E, a method for sealing a puncture site isillustrated. An expansible device 400 as described above is provided.The device 400 is inserted in the puncture site. The first expansiblemember 312 is deployed to an expanded configuration comprising aspherical shape. The second expansible member 402 is deployed to anexpanded configuration comprising a cylindrical shape. The first andsecond expansible members may be deployed sequentially orsimultaneously. Preferably, second expansible member 402 is deployedafter confirmation that the first expansible member 312 is against theinner wall of the vessel at the puncture site by pulling the tubularmember proximally until resistance is felt. The first expansible member312 is preferably deployed against the blood vessel wall 306. The secondexpansible member is preferably deployed against a tract 418 of tissue420. The second expansible member 402 may extend at least a portion ofthe tissue track 418 or the whole length of the tissue track 418 fromthe vessel wall 306 to a skin surface 422. Typically, the secondexpansible member 402 has a length in a range from about 0.1 inch toabout 2 inches.

After an adequate amount of time, the device 400 is un-deployed. Theun-deployment may include the un-deployment of both expansible members312 and 402 and removal of the device 400 or it may require a two stagesequential un-deployment. The two stage un-deployment may preferablycomprise un-deployment of the first expansible member 312 initiallyfollowed by un-deployment of the second expansible member 402 andremoval of the device 402 some time later.

It is apparent from the foregoing that there has been provided anexpansile device for use in blood vessels and tracts in the human bodyand more particularly for percutaneous occlusion of vascular accesssites in the human body and method of using and manufacturing the same.

Although the expansile device and method have been described principallyin use with the human body it should be appreciated that the expansiledevice and method also can be utilized with animals in a similar manner.

In addition, it should be appreciated that the expansile device can beused within many different natural and iatrogenically created tracts inthe body in order to provide for other therapeutic or prophylacticmodalities.

Thus, it is also apparent from the foregoing that there has beenprovided a expansile device and method for percutaneous access andocclusion of openings and tracts in the human body that have distinctadvantages over those heretofore provided.

1. A method for sealing a puncture site in a blood vessel wall at theend of a tissue tract, said method comprising: providing an expansibledevice having a tubular member, a first expansible member disposed on adistal end of the tubular member, a first deformable membrane at leastpartially disposed over the first expansible member, and a secondexpansible member disposed proximal to the first expansible member andon the distal end of the tubular member; inserting the expansible devicethrough the tissue tract so that the first expansible member goes pastthe puncture site and into a lumen of the blood vessel; causing astraight wire within the first expansible member to assume a helicalconfiguration such that the wire expands the first expansible member toan expanded configuration comprising a spherical shape, wherein theexpanded first expansible member provides a supporting framework to keepthe membrane taut and occlude the opening in the blood vessel wall whenpositioned over said opening; deploying the second expansible member toan expanded configuration comprising an elongate cylinder, wherein thecylinder has a length sufficient to extend from the penetration throughthe tissue tract, wherein deploying the second expansible membranecomprises inflating the second expansible member with a predeterminedvolume of air.
 2. The method of claim 1, wherein the first and secondexpansible members are deployed sequentially.
 3. The method of claim 1,wherein the first and second expansible members are deployedsimultaneously.